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List of Drug Master Files (JDMF) for Amantadine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. (1)

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01 Amantadine hydrochloride (1)

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01 China (1)

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223MF10070
333, Jiangnan Road, Hengdian, Dongy...
2011-05-27
2011-05-27
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Looking for 665-66-7 / Amantadine Hydrochloride API manufacturers, exporters & distributors?

Amantadine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Amantadine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Amantadine Hydrochloride manufacturer or Amantadine Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amantadine Hydrochloride manufacturer or Amantadine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Amantadine Hydrochloride API Price utilized in the formulation of products. Amantadine Hydrochloride API Price is not always fixed or binding as the Amantadine Hydrochloride Price is obtained through a variety of data sources. The Amantadine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Amantadine Hydrochloride

Synonyms

665-66-7, 1-adamantanamine hydrochloride, Amantadine hcl, Symmetrel, 1-aminoadamantane hydrochloride, Adamantan-1-amine hydrochloride

Cas Number

665-66-7

Unique Ingredient Identifier (UNII)

M6Q1EO9TD0

About Amantadine Hydrochloride

An antiviral that is used in the prophylactic or symptomatic treatment of influenza A. It is also used as an antiparkinsonian agent, to treat extrapyramidal reactions, and for postherpetic neuralgia. The mechanisms of its effects in movement disorders are not well understood but probably reflect an increase in synthesis and release of dopamine, with perhaps some inhibition of dopamine uptake.

Amantadine Manufacturers

A Amantadine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amantadine, including repackagers and relabelers. The FDA regulates Amantadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amantadine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Amantadine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Amantadine Suppliers

A Amantadine supplier is an individual or a company that provides Amantadine active pharmaceutical ingredient (API) or Amantadine finished formulations upon request. The Amantadine suppliers may include Amantadine API manufacturers, exporters, distributors and traders.

click here to find a list of Amantadine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Amantadine JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Amantadine Drug Master File in Japan (Amantadine JDMF) empowers Amantadine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Amantadine JDMF during the approval evaluation for pharmaceutical products. At the time of Amantadine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Amantadine suppliers with JDMF on PharmaCompass.

Amantadine Manufacturers | Traders | Suppliers

Amantadine Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Amantadine

Get in contact with the supplier of your choice:

  1. Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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